NCT06249763Completed
Effects of Gluten Free Diet in Ulcerative Colitis
Effects of Dietary Gluten on Gastrointestinal Symptoms in Ulcerative Colitis: a Randomised Crossover Trial.
Source: ClinicalTrials.gov · Last updated 12 Jan 2026
Brief summary (registry, in English)
The goal is to evaluate gastrointestinal symptoms and fatigue levels during a period of eating gluten free compared to a period of high gluten consumption in individuals with confirmed Ulcerative Colitis, and to identify clinical characteristics in the blood and microbiome of those improving from a gluten free diet. The main questions, the project aims to answer are: * What is the effect of eating gluten free on patient-reported gastrointestinal symptoms in patients with Ulcerative Colitis? * What is the effect of eating gluten free on patient-reported fatigue levels in patients with Ulcerative Colitis? * What are clinical differences between those improving and not improving on fatigue levels and gastrointestinal symptoms? During two study periods of one week each, participants will be eating gluten free supplemented with daily granola bars without and with high gluten content, respectively. During each active week, participants are asked to: * Eat gluten free and two daily granola bars delivered by the research team * Collect blood, stool and urine samples * Answer questionnaires about their symptoms, disease course, habitual lifestyle, and compliance to the protocol
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 31 Jan 2024
- Start date
- 11 Mar 2024
- Primary completion date
- 30 Oct 2024
- Lead sponsor
- University of Southern Denmark
- Diseases
- Ulcerative colitis
- NCT number
- NCT06249763
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 11 Mar 2024 to the primary completion date, 30 Oct 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment: Have received antibiotic treatment within 4 weeks prior to inclusion
- Treatment: Previous operation for UC
- Concomitant diagnoses: Coeliac Disease (positive Immunoglobolin A against transglutaminase, TGA-IgA) or any cancer diagnosis
Other illness
- Severe disease activity defined by 6 or more bloody stools per day and/or night and one of the following: fever, pulse ≥ 90, C-reactive protein (CRP) ≥ 30mg/L by the time of inclusion
- Other: Taking probiotics, are pregnant or breastfeeding, or have nut or wheat allergy
Age
- Age: \<18 years
Who the study is looking for
- Diagnosis: Ulcerative Colitis (UC)
- Language: Can read and understand Danish
- Treatment: No intention to change dose of, begin, or switch medication and biologic treatment within one month after inclusion
- Treatment: Medical and/or biologic treatment type and dose stable for at least 8-16 weeks prior to inclusion depending on the type of treatment
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital of Southern Jutland Coordinator of this site? Confirm its status | Aabenraa | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.